Gs1 healthcare voor een betere patientveiligheid

1. GS1 Healthcare –
Improving Patient
Safety
Ulrike Kreysa, Director Healthcare
GS1 Global Office, Brussels
GS1 Healthcare Nederland Conference,
Amsterdam, 27 January 2011

2. Standards – why do we care?
Regulations emerge worldwide
Supply Chain costs increase
Electronic Health Records
Medication errors
Counterfeiting
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© 2008 GS1

3. GS1 Standards in Healthcare …
Our vision
GS1 Healthcare envisions a future where
the healthcare sector utilises GS1 global
standards for all items, locations, people
and processes to drive patient safety and
supply chain efficiency improvements--
starting with the manufacturer and ending
with procedures or treatments for a specific
patient.
© 2008 GS1

4. Leading healthcare
organisations pave the way…
Corporate members of the global user group
© 2008 GS1

5. Need for standards in Healthcare
Diverging country requirements
Manufacturing headache
>
Additional cost and risk
© 2008 GS1

6. Leading healthcare
organisations pave the way…
Healthcare providers and Group Purchasing
Organisations going global
France Germany Netherlands Hong Kong Switzerland
Austria Germany USA Austria USA
Ireland Netherlands France USA USA
© 2008 GS1

7. Advancing global standards
in Healthcare
• Global Healthcare User Group
• Develop global healthcare standards
• Drive global harmonization
• Local Healthcare User Groups
• Drive adoption & implementation of GS1
Standards
• Help develop global healthcare standards
© 2008 GS1

8. Local Healthcare user groups
driving adoption
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© 2008 GS1

9. GS1 Healthcare around the World
Members global user group Local participation
Manufacturers Distributors/Healthcare Manufacturers Healthcare providers/Retailers
Abbott Laboratories providers/GPOs/T&L 3M Alfred Hospital (Australia)
Alcon Labs Cardinal Health (U.S.) Bayer Ascension Health (U.S.)
Amgen CH Aulnay sous Bois (France) Becton Dickinson Capital District Health (Canada)
Astra Zeneca Comparatio Health (Germany) Boehringer Ingelheim CHU de Québec (Canada)
Baxter CVS (U.S.) Coloplast CHU Dijon (France)
Becton Dickenson DHL Exel Supply Chain Draeger Medical HUG Geneva (Switzerland)
B. Braun Erasmus MC Rotterdam (NL) Genzyme London Drugs (U.K.)
Boston Scientific UNI.HA (representing 17 French Hospira Mayo Clinic (U.S.)
Bristol Myers Squibb university hospitals) Kimberly-Clark Sisters of Mercy (U.S.)
Cook Hong Kong Hospital Authorities Novo Nordisk Sobeys Pharmacy (U.K.)
Covidien McKesson (U.S.) Purdue Pharma UHCS Augusta VA (U.S.)
Edwards Lifescience Novation (U.S.) St. Jude Medical Walgreens (U.S.)
Fresenius Orthopädisches Spital Speising Wien Stryker Wal-Mart (U.S.)
Glaxo Smith Kline (Austria) Teva Pharmaceuticals …
Johnson & Johnson Premier (U.S.) Terumo Associations
King Pharmaceutical St. James Hospital, Dublin UCB AHA (U.S.)
Medtronic Marienhospital Herne (Germany) Upsher-Smith CIP/ACL (France)
Merck & Co. UMC Groningen (NL) … CHeS (U.S.)
Novartis Pharma University Kentucky Healthcare Distributors/Wholesalers EFPIA (Europe)
Pall Medical (U.S.) Aexxdis Eucomed (Europe)
Pfizer Wiener Krankenanstaltenverbund Amerinet FENIN (Spain)
Schering Plough (Austria) Amerisource Bergen GIRP (Europe)
Smiths Medical Non-voting members CH2 HDMA (U.S.)
Sakura Seiki AHRMM Depolabo International Hospital Federation
Cladimed Galexis JFMDA (Japan)
Solution provider EDQM – Council of Europe GAMMA Wholesale Medical Industry Association of
Axway FDA USA Geodis Australia
GHX Instituto Brasileiro de Ética McMahon NACDS (U.S.)
Concorrencial – ETCO Owens & Minor Patient Safety Foundation (U.S.)
© 2008 GS1 Public Health Agency of Canada … …
US DoD And many more…

10. Working with International
Organisations
International European Health Level 7 International
International
Organisation for Committee for Health
World Health Society for Blood
Standardization Standardization Terminology SDO
Organization Transfusion
International Society European
European United Nations
for Quality in Association of World Customs
Healthcare Medical Device Association of Organization
manufacturer Hospital
Pharmacists
© 2008 GS1

11. GS1 Standards for Healthcare
Standards development continues, but global
standards are ALREADY available to build on:
AIDC Application Standards for 90% of medical
products
AIDC Application Standards for small instruments
Healthcare extension in next GDSN release
Global Traceability Standard for Healthcare
GTIN Allocation Rules for Healthcare
Guideline for plasma derivatives
© 2008 GS1

12. Government & regulatory
developments
FDA Amendments Act of 2007
Serialised Numerical Identifiers (SNI) system for drugs – aligned
with GS1 standards (AI(21))
Authority to develop regulations establishing a Unique Device
Identification (UDI) system for medical devices
“Pharma Package” - Prevention of the entry into the legal supply
chain of medicinal products which are falsified in relation to their
identity, history or source, introducing a harmonised coding
system to enable traceability
Recast of Medical Device Directive - To establish a UDI System
EDQM Project: Track & Trace Service
Phase 2 (live demo development) start Q1 2011
© 2008 GS1

13. Government & regulatory
developments (cont’d)
China – Shanghai Regulation 7 November 2006 – Established
a traceability system for implantable medical devices in 2007
India – Ministry of Health & Family Welfare –
Tender requirements for GS1 Standards for all medical supplies procured by the
MoHFW
Australia – National eHealth Transition Authorities –
To accelerate the adoption of eHealth established:
• National Product Catalogue based on GS1 Standards
• GLN Registry with GS1 Australia
Turkey – Ministry of Health and SKG
• National databank for medical devices
• Track and Trace for pharmaceuticals based on GS1 standards – GS1 DataMatrix
with GTIN, lot/batch number, serial number and expiry date – already in place
France – enabling traceability
Identification of drugs with GS1 Data Matrix containing GTIN, lot/batch number and
expiry date – no serialisation - from 1 January 2011 onwards
© 2008 GS1

14. Industry developments
US – Sunrise dates – GLN 2010 and GTIN 2012 –
targeting for the adoption of GLN and GTIN by 2010
resp. 2012
US – Tender requirements – Endorsement by GPO’s
and healthcare providers envisioning tender
requirements for GS1 Standards
Canada – Sunrise dates – GLN 2010 and GTIN
2012 – targeting for the adoption of GLN and GTIN by
2010 resp. 2012
Canada – Tender requirements – Endorsement by
GPO’s and healthcare providers envisioning tender
requirements for GS1 Standards
Canada – Pharmaceutical Bar Coding Project -
ISMP Canada and CPSI
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© 2008 GS1

15. DataMatrix on pharmaceuticals
France: AFSSAPS Belgium: Pilot project unit Serbia: Pilot
regulation (2011) dose marking
Spain: Pilot
Korea: pharma regulatory
requirement (2011)
Switzerland:
SmartLog Pilot
Turkey: Regulatory Japan: option for
requirement (2010) instruments marking
Brazil: traceability
pilot successfully
completed – ANVISA
regulation
= country requires DataMatrix
= country using DataMatrix in pilots and/or developing
© 2008 GS1 requirement for DataMatrix 15

16. Position on Camera-Based scanners
(June 2007)
Preparing members, solutions providers and end
users for the future…
Get your copy at:
http://www.gs1.org/docs/healthcare/GS1_HUG_ps_Ca
mera_Based_Scanners.pdf
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© 2008 GS1

17. The need for global standards
• Healthcare is local
• Healthcare providers are local
• Regulations are local
• Healthcare is global
• Healthcare supply chains often cross borders
Country-by-country solutions are
not sufficient nor effective
© 2008 GS1

18. GS1 Standards in Healthcare
• Enable automatic identification
systems
• Enable traceability systems
• Enable « clean » data
GS1 Standards in Healthcare
improve patient safety worldwide
© 2008 GS1

19. 19th Global
GS1 Healthcare Conference
Washington
6-8 April 2011
More information: soon on www.gs1.org/healthcare
19th Global GS1 Healthcare Conference
Washington DC Metro Area – 6-8 April 2011
Registration open at www.gs1.org/healthcare
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© 2008 GS1

20. Contact Details
Ulrike Kreysa
GS1 Global Office
T +32-2-788.78.37
E ulrike.kreysa@ gs1.org
W www.gs1.org/healthcare